Home / Recalls / Precision Dose Inc. / D-0094-2022

D-0094-2022 Class II Terminated

Recalled by Precision Dose Inc. — South Beloit, IL

FDA drug recall D-0094-2022 was initiated by Precision Dose Inc. on Nov 1, 2021 and is designated Class II. Reason for recall: cGMP Deviations: Product manufactured with contaminated raw ingredient. The recall status is terminated (terminated Jul 14, 2024). Affected quantity: 166,920 unit dose cups.

Recall Details

Product Type: Drugs
Report Date: Nov 17, 2021
Initiation Date: Nov 1, 2021
Termination Date: Jul 14, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 166,920 unit dose cups

Product Description

Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup: 68094-231-59), in a) 30-count case (NDC 30-count case: 68094-231-62), and b) 100-count case (NDC 100-count case: 68094-231-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.

Reason for Recall

cGMP Deviations: Product manufactured with contaminated raw ingredient.

Distribution Pattern

Nationwide USA

Code Information

Lot#: 503670

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0094-2022
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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